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CTRI Number  CTRI/2023/11/059853 [Registered on: 15/11/2023] Trial Registered Prospectively
Last Modified On: 12/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two newer generation supraglottic airway devices Baska Mask and I Gel in short duration surgeries under general anesthesia 
Scientific Title of Study   Comparison of Baska Mask with I Gel in adult patients undergoing daycare surgeries under general anesthesia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sumiya Fathima 
Designation  Second year pg resident in Anesthesiology  
Affiliation  Dr Moopen’s Medical College  
Address  Pg resident Department of Anaesthesiology Dr Moopen’s Medical College Naseera Nagar Meppadi,Wayanad
Valil House, karthikappally p.o Alleppey 690516 Kerala
Wayanad
KERALA
673577
India 
Phone  8086492279  
Fax    
Email  sumiya.fathima.94@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Aruna Tegginmath  
Designation  Professor,Department of Anesthesiology 
Affiliation  Dr Moopen’s Medical College  
Address  Professor Department of Anaesthesiology Dr Moopen’s Medical College Naseera Nagar Meppadi,Wayanad

Wayanad
KERALA
673577
India 
Phone  9243507325  
Fax    
Email  shraddhakrupa27@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sumiya Fathima 
Designation  Second year pg resident in Anesthesiology  
Affiliation  Dr Moopen’s Medical College  
Address  Pg resident Department of Anaesthesiology Dr Moopen’s Medical College Naseera Nagar Meppadi,Wayanad
Valil House, karthikappally p.o Alleppey 690516 Kerala
Wayanad
KERALA
673577
India 
Phone  8086492279  
Fax    
Email  sumiya.fathima.94@gmail.com  
 
Source of Monetary or Material Support  
Dr Moopens Medical College Naseera Nagar Meppadi P.O Wayanad 673577 Kerala  
 
Primary Sponsor  
Name  Dr Moopens Medical College 
Address  Dr Moopens Medical College Naseera Nagar Meppadi Wayanad 673577 Kerala 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sumiya Fathima  Dr Moopens Medical College  Department of Anesthesiology 7th floor Hospital Complex
Wayanad
KERALA 		 8086492279

sumiya.fathima.94@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee (IEC) (Human Studies) DM WIMS, ECR/920/Inst/KL/2017/RR-20  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: I10||Essential (primary) hypertension, (2) ICD-10 Condition: E039||Hypothyroidism, unspecified, (3) ICD-10 Condition: D509||Iron deficiency anemia, unspecified, (4) ICD-10 Condition: E02||Subclinical iodine-deficiency hypothyroidism, (5) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BASKA MASK  Newer generation supraglottic airway device The Baska mask has a non-inflatable cuff, which is moulded to take up the shape of the supraglottic airway, potentially reducing the risk of oropharyngeal tissue and/or nerve damage induced by cuff overinflation, a known complication with other supraglottic airway devices . However, the cuff differs from other ‘non-inflatable’ cuffs in that it is continuous with the central channel of the device. As the pressure increases with positive pressure ventilation, the cuff is inflated; which may improve the seal, reducing leak and thus causing efficient ventilation. The baska mask incorporates an inlet that fits into the upper oesophagus and the dorsal surface of the cuff is moulded to direct any oropharyngeal contents away from the glottis and towards the side channels to which suction can be attached to facilitate aspiration of this space.These features may reduce the risk of pulmonary aspiration of secretions or gastric content that accumulate in the supraglottic area. There is an extended hand tab attached to the cuff that permits the operator to control the degree of flexion of the device during its insertion. 
Comparator Agent  I GEL  Supraglottic airway device I-gel developed by Mohammed Naser with an anatomically designed mask made of a gel like thermoplastic elastomer. It has features designed to separate the gastrointestinal and respiratory tracts and allows a gastric tube to be passed into the stomach. The tensile properties of the I-gel bowl, along with its shape and the ridge at its proximal end, contribute to the stability of the device upon insertion. Upon sliding beneath the pharyngo-epiglottic folds, it becomes narrower and longer, creating an outward force against the tissues. The ridge at the proximal bowl catches the base of the tongue, also keeping the device from moving upward and out of position (and the tip from moving out of the upper esophagus. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients planned for daycare surgeries
Planned for elective non head and neck surgical intervention by general anesthesia
ASA 1 AND 2
No relevant allergies (silicon)
BMI (20 to 30 kg/metre square)
 
 
ExclusionCriteria 
Details  Emergency surgeries
Neck pathology
Previous or anticipated problems with upper airway or upper GI tract
Predicted or previousLy documented upper airway
Pregnancy 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess efficacy and safety of BASKA MASK and I GEL in terms of airway sealing pressure, peak airway pressure,number of attempts,ease of insertion,post operative complications  1 min, 3 min, 5 min,10 min,20 min, 12 hours,24 hours,36hours post device insertion 
 
Secondary Outcome  
Outcome  TimePoints 
1.To compare and assess time taken for insertion, ease of insertion, number of attempts
2.T o compare and assess post operative complication like sore throat 		 1 min, 3 min,5 min,10 min,20 min
after insertion 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/12/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 02-03-2025 and end date provided 02-03-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   To compare Baska mask and I Gel in adult patients undergoing daycare surgeries under general anesthesia in terms of airway sealing pressure, peak airway pressure, hemodynamic changes and based on attempts in terms of number of attempts, ease of insertion, post operative complications like sorethroat with 88 patients as a single blinded randomised prospective controlled trial. 
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